D-0240-2021 Class II Terminated
FDA drug recall D-0240-2021 was initiated by Shane Erickson Inc on December 23, 2020 and is designated Class II. Reason for recall: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. The recall status is terminated (terminated September 29, 2023). Affected quantity: 42,157 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 3, 2021
- Initiation Date
- December 23, 2020
- Termination Date
- September 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,157 bottles
Product Description
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5
Reason for Recall
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Distribution Pattern
Nationwide USA and Canada
Code Information
Lot: MFG: 2020/05/10 L/N: 20200510-3